ProtocolInternational Journal of Clinical Trials
Publication: Internet-based cognitive behavioral therapy versus internet-based modified present-centered therapy for world trade center responders and survivors with posttraumatic stress disorder: rationale and design of a randomized controlled trial
Int J Clin Trials. 2021;8(3):202-210.DOI10.18203/2349-3259.ijct20212843
Abstract
Background Nearly two decades following the 9/11/2001 world trade center (WTC) attacks, a substantial proportion of WTC rescue and recovery workers (“responders”) and WTC survivors continue to experience WTC-related posttraumatic stress disorder (PTSD) symptoms. Internet-based cognitive behavioral therapies (I-CBT) are short-term, evidence-based, scalable treatments with the potential to reach large numbers of symptomatic WTC workers and survivors. However, no I-CBT studies have been conducted in the WTC cohort.
Methods This report describes the rationale and design of an ongoing randomized controlled trial comparing integrative testimonial therapy (ITT), an I-CBT, to an active comparison treatment, internet-based modified present-centered therapy. The primary aim is to evaluate the efficacy of ITT in mitigating WTC-related PTSD symptoms in WTC responders and survivors with full or subthreshold WTC-related PTSD. The efficacy of ITT in reducing comorbid depressive and anxiety symptoms, and improving functioning, quality of life, and post-traumatic growth will additionally be evaluated. Saliva samples are also collected to explore genetic and epigenetic biomarkers of treatment response.
Conclusions This is the first I-CBT trial to compare ITT to a credible and active treatment, controlling for critical third-variable explanations of superiority (e.g., non-specific therapy effects). This RCT bridges an important research gap in the rising field of I-CBT interventions and adds to the literature on the design of trials investigating evidence-based treatments for PTSD in WTC- and other trauma-affected populations. Trial registration: This trial was registered on clinicalTrials.gov on May 16, 2017 (NCT03154151).
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Affiliations
- Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA Department of Psychology, Rutgers, The State University of New Jersey, New Brunswick, NJ USA
- Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA
- Department of Clinical Psychological Intervention, Freie Universität Berlin, Germany Center Ueberleben, Berlin, Germany
- VA Boston Healthcare System, Boston, MA, USA Mental Illness Research, Education and Clinical Center, James J. Peters Veterans’ Administration Medical Center, Bronx, New York, USA
- Department of Psychiatry, Columbia University; New York State Psychiatric Institute, New York, NY, USA
- VA Boston Healthcare System, Boston, MA, USA Department of Psychiatry, Boston University School of Medicine, Boston, MA, USA Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA
- Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA Mental Illness Research, Education and Clinical Center, James J. Peters Veterans’ Administration Medical Center, Bronx, New York, USA Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, NY, USA Seaver Autism Center for Research and Treatment, Icahn School of Medicine at Mount Sinai, New York, NY, USA
- Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA Mental Illness Research, Education and Clinical Center, James J. Peters Veterans’ Administration Medical Center, Bronx, New York, USA Department of Neuroscience, Icahn School of Medicine at Mount Sinai, New York, NY, USA
- Department of Clinical Psychological Intervention, Freie Universität Berlin, Germany
- Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA United States Department of Veterans Affairs National Center for Post-traumatic Stress Disorder, Clinical Neurosciences Division, VA Connecticut Healthcare System, West Haven, CT, USAA